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Notification to Poison Centres, Draft Regulation

HSEP News Bulletin by Elaine Campling, the Product Safety Manager of Fujifilm Speciality Ink Systems, chair of ESMA Health, Safety and Environmental Protection Committee.

ESMA members may already have been circulated with the EU Commission draft regulation and new Annex VIII to CLP on the harmonised requirements for notification of hazardous mixtures to poisons centres, by their national authorities or trade associations. National authorities are requesting comments from stakeholders on the draft documents with a limited response time, as they are due for discussion at the next REACH Committee meeting on 16-17 March 2016, with a vote expected in April.

The impact of the regulation will depend on whether you supply mixtures for consumer, professional or industrial use. Suppliers of industrial mixtures benefit from extended timescales, with notification commencing on 1 July 2023 (and a sunset period until 1 January 2025) and the option of limited notification (consisting of the safety data sheet), providing “rapid access to additional product information” is provided by means of a 24/7 emergency response telephone number.

Suppliers of hazardous mixtures for non-industrial use, and industrial mixtures where a 24/7 emergency contact is not in place, will find that the proposed regulation significantly limits generic notification for products such as printing inks, which differ only in the level of pigmentation, since the cut off is 10% for the generic components of the mixture.

Printing inks and other products containing substances with generic identifiers often exceed this limit, meaning that each product within a range will need to be notified to the poison centres. Notification must be in the official language, or languages of the Member State where mixture is placed on the market (unless otherwise allowed).

The next HSEP committee meeting takes place on 22 April 2016 in Rome. All ESMA members are welcome to participate in the committee meetings and benefit from sharing Information, knowledge and working together to manage complex regulatory issues. Please go to the HSEP Committee page to register your attendance.

ESMA: Connecting the Dots of the Printing Industry

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